Aims
There is an increasing awareness of the evidence-based selection of outcomes to be measured in clinical trials and clinical practice. Currently, there is no core outcome set (COS) for cardio-oncology, which may hinder the (inter)national comparison of the effectiveness of research and the quality of cardio-oncology care. The aim of this study is to develop a standard and pragmatic patient-centred outcome set to assess and monitor cancer patients and survivors at risk of or with cardiovascular diseases.
Methods & results
A list of outcome domains was generated through a review of registries and guidelines, and six patient interviews. The project team reviewed and refined the outcome domains prior to starting a two-round Delphi procedure conducted between January-June 2022. The panellists, including healthcare providers and researchers, were invited to rate the importance of the outcomes. 26 experts from 11 countries rated a list of 93 outcomes (round 1) and 63 outcomes (round 2) to gain consensus on a list of outcome measures, and of demographic factors, health status and treatment variables. The final COS includes 15 outcome measures, reflecting four core areas: life impact (n = 2), pathophysiological manifestations (n = 9), resource use/economic impact (n = 1), and mortality/survival (n = 3). Next, six demographic factors, 21 health status, three cardiovascular and nine cancer variables were included.
Conclusion
This is the first international development of a COS for cardio-oncology. This set aims to facilitate (inter)national comparison in cardio-oncology care, using standardised parameters and meaningful patient-centred outcomes for research and quality of care assessments.
The aim of this study is to develop a standard and pragmatic patient-centred outcome set to assess and monitor cancer patients and survivors at risk of or with cardiovascular diseases.
Karen Van den Bussche, principal investigator
Berlinde von Kemp
Bénédicte Manderlier
Katrien Beeckman
Bernard Cosyns
Disease Category: Heart & circulation
Disease Name: Cardio-oncology
Age Range: 18 - 99
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Delphi process
- Interview
- Literature review
A list of outcomes and measures will be generated through review of existing registries and standard sets. International experts and patients will be contacted to gain input. Consensus will be reached using a Delphi procedure in which experts will be invited to rate the importance of each outcome.